Daytona Small Stature
Rod Connector, 4.5 x 4.5, Small Stature, 3mm OZAT
11manufacturers in China registered for this device type
79catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K200381 |
| Record published | 2020-08-12 |
| Record revised | 2025-10-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 79-0328 | In distribution | |
| 79-6585 | In distribution | |
| 79-7545 | In distribution | |
| 79-0318 | In distribution | |
| 777530 | In distribution | |
| 775030 | In distribution | |
| 79-5540 | In distribution | |
| 79-7500 | In distribution | |
| 774525 | In distribution | |
| 79-6545 | In distribution | |
| 79-4020 | In distribution | |
| 775525 | In distribution | |
| 78-0450 | In distribution | |
| 79-5560 | In distribution | |
| 79-6500 | In distribution | |
| 76-1070 | In distribution | |
| 79-6580 | In distribution | |
| 79-6590 | In distribution | |
| 79-0160 | In distribution | |
| 79-7550 | In distribution | |
| 777540 | In distribution | |
| 79-7590 | In distribution | |
| 79-7560 | In distribution | |
| 774550 | In distribution | |
| 79-6560 | In distribution | |
| 776580 | In distribution | |
| 76-0446 | In distribution | |
| 79-5035 | In distribution | |
| 78-0090 | In distribution | |
| 97-6506 | In distribution | |
| 777500 | In distribution | |
| 79-0011 | In distribution | |
| 77-6040 | In distribution | |
| 774555 | In distribution | |
| 774540 | In distribution | |
| 776500 | In distribution | |
| 79-5535 | In distribution | |
| 79-6535 | In distribution | |
| 76-1040 | In distribution | |
| 777545 | In distribution | |
| 777570 | In distribution | |
| 776045 | In distribution | |
| 777595 | In distribution | |
| 78-0070 | In distribution | |
| 79-0130 | In distribution | |
| 78-0060 | In distribution | |
| 79-0320 | In distribution | |
| 79-4555 | In distribution | |
| 79-6555 | In distribution | |
| 79-6020 | In distribution | |
| 775560 | In distribution | |
| 97-6511 | In distribution | |
| 79-6540 | In distribution | |
| 776565 | In distribution | |
| 76-0434 | In distribution | |
| 78-0250 | In distribution | |
| 79-4050 | In distribution | |
| 776550 | In distribution | |
| 79-0060 | In distribution | |
| 76-1030 | In distribution | |
| 79-5040 | In distribution | |
| 79-0314 | In distribution | |
| 97-6509 | In distribution | |
| 775060 | In distribution | |
| 79-6025 | In distribution | |
| 776585 | In distribution | |
| 79-5520 | In distribution | |
| 79-4045 | In distribution | |
| 79-7595 | In distribution | |
| 79-6035 | In distribution | |
| 97-6514 | In distribution | |
| 79-0005 | In distribution | |
| 777555 | In distribution | |
| 78-0300 | In distribution | |
| 777510 | In distribution | |
| 774560 | In distribution | |
| 777585 | In distribution | |
| 79-7555 | In distribution | |
| 78-0100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.